Coreg

— THERAPEUTIC CATEGORIES —
  • CHF and arrhythmias
  • Hypertension
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Coreg Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Carvedilol 3.125mg, 6.25mg, 12.5mg, 25mg; tabs.

    Pharmacological Class

    Noncardioselective beta-blocker/alpha-1 blocker.

    See Also

    How Supplied

    CR caps—30; Tabs—100

    How Supplied

    Coreg Tablets

    • The white, oval, film-coated tablets are available in bottles of 100 in the following strengths:

      • 3.125 mg – engraved with "39" and "WP"

      • 6.25 mg – engraved with "4140" and "WP"

      • 12.5 mg – engraved with "4141" and "WP"

      • 25 mg – engraved with "4142" and "WP"

    • The 6.25 mg, 12.5 mg, and 25 mg tablets are TILTAB tablets.

    Storage

    Store below 30°C (86°F). Protect from moisture. Dispense in a tight, light‑resistant container.

    Manufacturer

    Woodward Pharma Services LLC

    Generic Availability

    YES

    Mechanism of Action

    Carvedilol phosphate is a non-selective β-adrenergic blocking agent with α1-blocking activity. It has no intrinsic sympathomimetic activity.

    Coreg Indications

    Indications

    Mild to severe heart failure (HF), to increase survival and reduce hospitalization risk. To reduce cardiovascular mortality post-MI with left ventricular ejection fraction ≤40%.

    Coreg Dosage and Administration

    Adult

    Individualize. Monitor dose increases closely. Take with food. ≥18yrs: CHF: initially 3.125mg twice daily for 2 weeks, may double dose every 2 weeks if tolerated; mild to moderate HF (>85kg): usual max 50mg twice daily. Reduce dose if pulse <55. Post-MI: initially 6.25mg twice daily; increase to 12.5mg twice daily after 3–10 days if tolerated; then to target dose 25mg twice daily. Low BP or heart rate, or fluid retention: may start at 3.125mg twice daily.

    Children

    <18yrs: not recommended.

    Coreg Contraindications

    Contraindications

    Cardiogenic shock or decompensated HF requiring intravenous inotropic therapy. Asthma, related bronchospastic conditions. 2nd or 3rd-degree AV block, sick sinus syndrome, or severe bradycardia, unless paced. Severe hepatic impairment.

    Coreg Boxed Warnings

    Not Applicable

    Coreg Warnings/Precautions

    Warnings/Precautions

    Peripheral vascular disease. Nonallergic bronchospastic disease (eg, chronic bronchitis, emphyema). Diabetes (monitor blood glucose). Hyperthyroidism. Monitor renal function in ischemic heart disease, diffuse vascular disease, underlying renal insufficiency, and/or if systolic BP <100 mmHg. Heart failure or fluid retention; initiation of therapy may temporarily worsen signs and symptoms; increase diuretic dose and do not increase carvediolol dose if symptoms occur. Do not routinely withdraw treatment prior to major surgery. Avoid abrupt cessation (discontinue over 1–2 weeks if possible). May mask signs of hyperthyroidism; abrupt cessation may worsen hyperthyroidism or precipitate thyroid storm. Cataract surgery (intraoperative floppy iris syndrome possible). Prinzmetal's angina. Pheochromocytoma. Elderly. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Cessation of Therapy

    • Avoid abrupt cessation in patients with coronary artery disease.

    • Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias may occur in patients with angina after abrupt cessation.

    • Discontinue Coreg over 1 to 2 weeks if possible, and monitor the patient closely when discontinuing Coreg and advise to limit physical activity to a minimum. Promptly reinstitute Coreg if angina worsens or acute coronary insufficiency develops during discontinuation.

    Bradycardia

    • Bradycardia may occur. Reduce dose of Coreg if pulse rate drops <55 beats per minute.

    Hypotension

    • Hypotension and postural hypotension may occur, along with syncope.

    • To reduce the risk for syncope or excessive hypotension, initiate patients on a low dose of Coreg with food and gradually up-titrate.

    • Avoid driving or handling hazardous tasks when initiating treatment due to a risk for syncope.

    Heart Failure/Fluid Retention

    • During up-titration, the use of carvedilol may cause worsening heart failure or fluid retention. If these symptoms occur, increase diuretics and do not advance the dose of carvedilol until clinical stability resumes.

    • Occasionally it is necessary to lower the carvedilol dose or temporarily discontinue it.

    Non-allergic Bronchospasm

    • Use caution in patients who do not respond to, or cannot tolerate, other antihypertensive agents. Advise to use the smallest effective dose.

    Glycemic Control in Type 2 Diabetes

    • May mask some of the manifestations of hypoglycemia, particularly tachcardia. Nonselective beta-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. Patients subject to spontaneous hypoglycemia or diabetic patients receiving insulin or oral hypoglycemic agents should be cautioned about these possibilities.

    • Carvedilol may worsen hyperglycemia in patients with HF and diabetes.

    • Monitor blood glucose during initiation, dose adjustments, or discontinuing therapy.

    Peripheral Vascular Disease

    • May precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Exercise caution.

    Deterioration of Renal Function

    • In patients with heart failure, the use of carvedilol has rarely resulted in deterioration of renal function.

    • Risk factors include systolic BP <100mmHg, ischemic heart disease, and diffuse vascular disease, and/or underlying renal insufficiency. Monitor renal function during up-titration, discontinuation, or dose reduction in patients with these risk factors.

    Major Surgery

    • Do not routinely withdraw chronically administered beta-blocker therapy prior to major surgery.

    • During major surgery, the use of beta-blockers may augment the risk of general anesthesia and surgical procedures due the hearts inability to respond to reflex adrenergic stimuli.

    Thyrotoxicosis

    • May mask clinical signs of hyperthyroidism (eg, tachycardia). Abrupt withdrawal may lead to an exacerbation of hyperthyroidism or may precipitate thyroid storm.

    Pheochromocytoma

    • In patients with pheochromocytoma, initiate an alpha-blocking agent prior to the use of any beta-blocking agent.

    • Use caution when administering carvedilol to patients suspected of having pheochromocytoma.

    Prinzmetal's Variant Angina

    • Agents with non-selective β-blocking activity may provoke chest pain in patients with Prinzmetal's variant angina. 

    • Use caution in patients suspected of having Prinzmetal's variant angina.

    Risk of Anaphylactic Reaction

    • Patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge while taking beta-blockers.

    • These patients may be unresponsive to epinephrine used to treat allergic reaction.

    Intraoperative Floppy Iris Syndrome (IFIS)

    • IFIS has been observed during cataract surgery in some patients treated with alpha-1 blockers.

    Pregnancy Considerations

    Risk Summary

    • Available data in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes.

    • There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. 

    • Use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate.

    Clinical Considerations

    • Disease-Associated Maternal and/or Embryo-Fetal Risk: Pregnant women with hypertension should be carefully monitored and managed accordingly. Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. 

    • Fetal/Neonatal Adverse Reactions: Neonates of women with hypertension who are treated with beta-blockers during the third trimester of pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly.

    Nursing Mother Considerations

    Risk Summary

    • No data on the presence of carvedilol in human milk, the effects on the breastfed infant, or the effects on milk production. 

    • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Coreg and any potential adverse effects on the breastfed infant from Coreg or from the underlying maternal condition.

    Pediatric Considerations

    • Efficacy of Coreg has not been established in patients younger than 18 years.

    Coreg Pharmacokinetics

    Absorption

    Rapidly and extensively absorbed. Absolute bioavailability: approximately 25–35%.

    Distribution

    Plasma protein bound: >98%.

    Steady-state volume of distribution: approximately 115 L.

    Plasma clearance ranges from 500-700 mL/min.

    Metabolism

    Hepatic (aromatic ring oxidation, glucuronidation).

    Elimination

    Fecal. Half-life: ~7–10hrs.

    Coreg Interactions

    Interactions

    May be potentiated by CYP2D6 poor metabolizers or inhibitors (eg, quinidine, fluoxetine, paroxetine, propafenone), cimetidine. Monitor closely for severe bradycardia and/or hypotension with catecholamine depletors (eg, reserpine, MAOIs), clonidine. Antagonized by rifampin. Caution with calcium channel blockers (eg, verapamil, diltiazem) that affect cardiac conduction; monitor ECG, BP. May potentiate antidiabetic agents; monitor blood glucose. Concomitant use with amiodarone or other CYP2C9 inhibitors (eg, fluconazole) may enhance β-blocking activity; monitor for bradycardia or heart block. Monitor digoxin, cyclosporine when changing carvedilol dose. May increase the risks of general anesthesia and surgical procedures.

    Coreg Adverse Reactions

    Adverse Reactions

    Dizziness, edema, hypotension, syncope, bradycardia, AV block, GI upset, hyperglycemia, weight gain, abnormal vision.

    Coreg Clinical Trials

    Clinical Trials

    Mild to Moderate Heart Failure (HF)

    • Carvedilol was evaluated in patients with mild to moderate HF in 5 multicenter, placebo-controlled trials, and in 1 active-controlled trial (COMET).

    • There were 4 US multicenter, double-blind, placebo-controlled trials which included 1094 patients with NYHA II-III HF and ejection fraction less than or equal to 0.35. Most of the patients were on digitalis, diuretics, and an ACE inhibitor at trial entry. There was an Australia-New Zealand double-blind, placebo-controlled trial which included 415 patients with less severe HF. All patients tolerated a 2-week course of carvedilol 6.25mg twice daily. 

    • The primary endpoint was either progression of HF (1 US trial) or exercise tolerance (2 US trial and the Australia-New Zealand trial). 

    • Slowing Progression of HF:

      • One US multicenter trial (366 subjects) had as its primary end point the sum of cardiovascular mortality, cardiovascular hospitalization, and sustained increase in heart failure medications. Heart failure progression was reduced, during an average follow‑up of 7 months, by 48% (P =.008).

      • In the Australia‑New Zealand trial, death and total hospitalizations were reduced by about 25% over 18 to 24 months. 

      • In the 3 largest U.S. trials, death and total hospitalizations were reduced by 19%, 39%, and 49%, nominally statistically significant in the last 2 trials. The Australia‑New Zealand results were statistically borderline.

    • Functional Measures:

      • None of the multicenter trials had NYHA classification as a primary end point, but all such trials had it as a secondary end point. There was at least a trend toward improvement in NYHA class in a l trials.

    • Subjective Measures: 

      • Health-related quality of life, as measured with a standard questionnaire (a primary end point in 1 trial), was unaffected by carvedilol. However, patients' and investigators' global assessments showed significant improvement in most trials.

    • Mortality: 

      • Death was not a pre-specified end point in any trial but was analyzed in all trials. Overall, in these 4 US trials, mortality was reduced, nominally significantly so in 2 trials.

    The COMET Trial

    • The COMET trial included 3029 subjects with NYHA class II-IV heart failure (left ventricular ejection fraction less than or equal to 35%) who were randomly assigned to receive either carvedilol (target dose: 25mg twice daily) or immediate-release metoprolol tartrate (target dose: 50mg twice daily). The mean age of the subjects was approximately 62 years, 80% were males, and the mean left ventricular ejection fraction at baseline was 26%. Approximately 96% of the subjects had NYHA class II or III HF.

    • The primary end points were all-cause mortality and the composite of death plus hospitalization for any reason.

    • All-cause mortality was 34% in the subjects treated with carvedilol and was 40% in the immediate-release metoprolol group (P =.0017; hazard ratio = 0.83, 95% CI, 0.74-0.93). The effect on mortality was primarily due to a reduction in cardiovascular death. The difference between the 2 groups with respect to the composite end point was not significant (P =.122). The estimated mean survival was 8.0 years with carvedilol and 6.6 years with immediate-release metoprolol.

    Severe Heart Failure (COPERNICUS)

    • The COPERNICUS trial included 2289 patients with HF at rest or with minimal exertion and LVEF <25% (mean 20%), despite digitalis (66%), diuretics (99%) and ACE inhibitors (89%) who were randomly assigned to receive placebo or carvedilol.

    • Patients were up-titrated from a starting dose of 3.125mg twice daily to a maximum tolerated dose or up to 25mg twice daily over 6 weeks.

    • The primary end point was all-cause mortality, but cause-specific mortality and the risk of death or hospitalization (tota, CV or HF) were also examined.

    • The trial was stopped after a median follow‑up of 10 months because of an observed 35% reduction in mortality (from 19.7% per patient-year on placebo to 12.8% on carvedilol; hazard ratio 0.65, 95% CI: 0.52 to 0.81, P =.0014, adjusted).

    • The effect on mortality was principally the result of a reduction in the rate of sudden death among subjects without worsening heart failure. 

    • Fewer subjects on carvedilol than on placebo were hospitalized for any reason (372 vs 432, P =.0029), for cardiovascular reasons (246 vs 314, P =.0003), or for worsening heart failure (198 vs 268, P =.0001).

    Left Ventricular Dysfunction following Myocardial Infarction

    • The double-blind CAPICORN trial included 1959 patients with a recent MI (within 21 days) and LVEF of ≤40%, with (47%) or without symptoms of HF. Patients initially received carvedilol at 6.25mg twice daily then titrated as tolerated to 25mg twice daily. Subjects had to have a systolic blood pressure greater than 90 mm Hg, a sitting heart rate greater than 60 beats per minute, and no contraindication to β‑blocker use.

    • All‑cause mortality was 15% in the placebo group and 12% in the carvedilol group, indicating a 23% risk reduction in subjects treated with carvedilol (95% CI: 2% to 40%, P =.03).

    • There was also a significant 40% reduction in fatal or non-fatal myocardial infarction observed in the group treated with carvedilol (95% CI: 11% to 60%, P =.01). A similar reduction in the risk of myocardial infarction was also observed in a meta-analysis of placebo- controlled trials of carvedilol in heart failure.

    Coreg Note

    Not Applicable

    Coreg Patient Counseling

    See Literature

    Coreg Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Carvedilol 3.125mg, 6.25mg, 12.5mg, 25mg; tabs.

    Pharmacological Class

    Noncardioselective beta-blocker/alpha-1 blocker.

    See Also

    How Supplied

    CR caps—30; Tabs—100

    How Supplied

    Coreg Tablets

    • The white, oval, film-coated tablets are available in bottles of 100 in the following strengths:

      • 3.125 mg – engraved with "39" and "WP"

      • 6.25 mg – engraved with "4140" and "WP"

      • 12.5 mg – engraved with "4141" and "WP"

      • 25 mg – engraved with "4142" and "WP"

    • The 6.25 mg, 12.5 mg, and 25 mg tablets are TILTAB tablets.

    Storage

    Store below 30°C (86°F). Protect from moisture. Dispense in a tight, light‑resistant container.

    Manufacturer

    Woodward Pharma Services LLC

    Generic Availability

    YES

    Mechanism of Action

    Carvedilol phosphate is a non-selective β-adrenergic blocking agent with α1-blocking activity. It has no intrinsic sympathomimetic activity.

    Coreg Indications

    Indications

    Hypertension.

    Coreg Dosage and Administration

    Adult

    Individualize. Take with food. ≥18yrs: initially 6.25mg twice daily; may increase as tolerated at 1–2 week intervals to 12.5mg twice daily. Max 25mg twice daily.

    Children

    <18yrs: not recommended.

    Coreg Contraindications

    Contraindications

    Cardiogenic shock or decompensated HF requiring intravenous inotropic therapy. Asthma, related bronchospastic conditions. 2nd or 3rd-degree AV block, sick sinus syndrome, or severe bradycardia, unless paced. Severe hepatic impairment.

    Coreg Boxed Warnings

    Not Applicable

    Coreg Warnings/Precautions

    Warnings/Precautions

    Peripheral vascular disease. Nonallergic bronchospastic disease (eg, chronic bronchitis, emphyema). Diabetes (monitor blood glucose). Hyperthyroidism. Monitor renal function in ischemic heart disease, diffuse vascular disease, underlying renal insufficiency, and/or if systolic BP <100 mmHg. Heart failure or fluid retention; initiation of therapy may temporarily worsen signs and symptoms; increase diuretic dose and do not increase carvediolol dose if symptoms occur. Do not routinely withdraw treatment prior to major surgery. Avoid abrupt cessation (discontinue over 1–2 weeks if possible). May mask signs of hyperthyroidism; abrupt cessation may worsen hyperthyroidism or precipitate thyroid storm. Cataract surgery (intraoperative floppy iris syndrome possible). Prinzmetal's angina. Pheochromocytoma. Elderly. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Cessation of Therapy

    • Avoid abrupt cessation in patients with coronary artery disease.

    • Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias may occur in patients with angina after abrupt cessation.

    • Discontinue Coreg CR over 1 to 2 weeks if possible, and monitor the patient closely when discontinuing Coreg CR and advise to limit physical activity to a minimum. Promptly reinstitute Coreg CR if angina worsens or acute coronary insufficiency develops during discontinuation.

    Bradycardia

    • Bradycardia may occur. Reduce dose of Coreg CR if pulse rate drops <55 beats per minute.

    Hypotension

    • Hypotension and postural hypotension may occur, along with syncope.

    • To reduce the risk for syncope or excessive hypotension, initiate patients on a low dose of Coreg CR with food and gradually up-titrate.

    • Avoid driving or handling hazardous tasks when initiating treatment due to a risk for syncope.

    Heart Failure/Fluid Retention

    • During up-titration, the use of carvedilol may cause worsening heart failure or fluid retention. If these symptoms occur, increase diuretics and do not advance the dose of carvedilol until clinical stability resumes.

    • Occasionally it is necessary to lower the carvedilol dose or temporarily discontinue it.

    Non-allergic Bronchospasm

    • Use caution in patients who do not respond to, or cannot tolerate, other antihypertensive agents. Advise to use the smallest effective dose.

    Glycemic Control in Type 2 Diabetes

    • May mask some of the manifestations of hypoglycemia, particularly tachcardia. Nonselective beta-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. Patients subject to spontaneous hypoglycemia or diabetic patients receiving insulin or oral hypoglycemic agents should be cautioned about these possibilities.

    • Carvedilol may worsen hyperglycemia in patients with HF and diabetes.

    • Monitor blood glucose during initiation, dose adjustments, or discontinuing therapy.

    Peripheral Vascular Disease

    • May precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Exercise caution.

    Deterioration of Renal Function

    • In patients with heart failure, the use of carvedilol has rarely resulted in deterioration of renal function.

    • Risk factors include systolic BP <100mmHg, ischemic heart disease, and diffuse vascular disease, and/or underlying renal insufficiency. Monitor renal function during up-titration, discontinuation, or dose reduction in patients with these risk factors.

    Major Surgery

    • Do not routinely withdraw chronically administered beta-blocker therapy prior to major surgery.

    • During major surgery, the use of beta-blockers may augment the risk of general anesthesia and surgical procedures due the hearts inability to respond to reflex adrenergic stimuli.

    Thyrotoxicosis

    • May mask clinical signs of hyperthyroidism (eg, tachycardia). Abrupt withdrawal may lead to an exacerbation of hyperthyroidism or may precipitate thyroid storm.

    Pheochromocytoma

    • In patients with pheochromocytoma, initiate an alpha-blocking agent prior to the use of any beta-blocking agent.

    • Use caution when administering carvedilol to patients suspected of having pheochromocytoma.

    Prinzmetal's Variant Angina

    • Agents with non-selective β-blocking activity may provoke chest pain in patients with Prinzmetal's variant angina. 

    • Use caution in patients suspected of having Prinzmetal's variant angina.

    Risk of Anaphylactic Reaction

    • Patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge while taking beta-blockers.

    • These patients may be unresponsive to epinephrine used to treat allergic reaction.

    Intraoperative Floppy Iris Syndrome (IFIS)

    • IFIS has been observed during cataract surgery in some patients treated with alpha-1 blockers.

    Pregnancy Considerations

    Risk Summary

    • Available data in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes.

    • There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. 

    • Use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate.

    Clinical Considerations

    • Disease-Associated Maternal and/or Embryo-Fetal Risk: Pregnant women with hypertension should be carefully monitored and managed accordingly. Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. 

    • Fetal/Neonatal Adverse Reactions: Neonates of women with hypertension who are treated with beta-blockers during the third trimester of pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly.

    Nursing Mother Considerations

    Risk Summary

    • No data on the presence of carvedilol in human milk, the effects on the breastfed infant, or the effects on milk production. 

    • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Coreg CR and any potential adverse effects on the breastfed infant from Coreg CR or from the underlying maternal condition.

    Pediatric Considerations

    • Efficacy of Coreg CR has not been established in patients younger than 18 years.

    Coreg Pharmacokinetics

    Absorption

    Rapidly and extensively absorbed. Absolute bioavailability: approximately 25–35%.

    Distribution

    Plasma protein bound: >98%.

    Steady-state volume of distribution: approximately 115 L.

    Plasma clearance ranges from 500-700 mL/min.

    Metabolism

    Hepatic (aromatic ring oxidation, glucuronidation).

    Elimination

    Fecal. Half-life: ~7–10hrs.

    Coreg Interactions

    Interactions

    May be potentiated by CYP2D6 poor metabolizers or inhibitors (eg, quinidine, fluoxetine, paroxetine, propafenone), cimetidine. Monitor closely for severe bradycardia and/or hypotension with catecholamine depletors (eg, reserpine, MAOIs), clonidine. Antagonized by rifampin. Caution with calcium channel blockers (eg, verapamil, diltiazem) that affect cardiac conduction; monitor ECG, BP. May potentiate antidiabetic agents; monitor blood glucose. Concomitant use with amiodarone or other CYP2C9 inhibitors (eg, fluconazole) may enhance β-blocking activity; monitor for bradycardia or heart block. Monitor digoxin, cyclosporine when changing carvedilol dose. May increase the risks of general anesthesia and surgical procedures.

    Coreg Adverse Reactions

    Adverse Reactions

    Dizziness, edema, hypotension, syncope, bradycardia, AV block, GI upset, hyperglycemia, weight gain, abnormal vision.

    Coreg Clinical Trials

    Clinical Trials

    Hypertension

    • Approval was based on data from 2 placebo-controlled trials that evaluated the efficacy of carvedilol administered twice daily at total daily doses of 12.5mg to 50mg.

    • The sitting trough (12-hour) blood pressure was reduced by ~9/5.5 mmHg at carvedilol 50mg per day and reduced by ~ 7.5/3.5mmHg at carvedilol 25mg per day

    • HR reduced by about 7.5 beats per minute at 50mg per day.

    • Peak antihypertensive effect occurred at 1 to 2 hours post dose.

    Hypertension with Type 2 Diabetes Mellitus

    • The double-blind GEMINI trial evaluated carvedilol, added to an ACE inhibitor or angiotensin- receptor blocker, in patients with mild‑to‑moderate hypertension and well-controlled type 2 diabetes mellitus. 

    • The mean HbA1c at baseline was 7.2%. Carvedilol was titrated to a mean dose of 17.5 mg twice daily and maintained for 5 months. Carvedilol had no adverse effect on glycemic control, based on HbA1c measurements (mean change from baseline of 0.02%, 95% CI: ‑0.06 to 0.10, P = NS)

    Coreg Note

    Not Applicable

    Coreg Patient Counseling

    See Literature

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